Date: 2017-11-16
Type of information: Granting of a Market Authorisation in the US
Product name: Sutent®
Compound: sunitinib
Therapeutic area: Cancer - Oncology
Action mechanism:
- kinase inhibitor/multi-kinase inhibitor. Sutent® (sunitinib malate) is an oral multi-kinase inhibitor that was approved in the United States in 2006 for the treatment of advanced renal cell carcinoma. It is currently approved in 119 countries and is the most prescribed among oral medications approved for the treatment of advanced RCC in the United States. Worldwide more than 250,000 patients across diagnoses have been treated with Sutent® in its approved indications of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumors (pNET).
Company: Pfizer (USA - NY)
Disease: treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy
Latest news:
- • On November 16, 2017, the FDA has approved a new indication expanding the use of Sutent® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy (surgical removal of the cancerous kidney).
- The approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received Sutent® compared to placebo in the adjuvant setting.
- The S-TRAC trial was a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 trial of Sutent® versus placebo in 615 patients with clear cell histology and high risk of recurrent renal cell carcinoma following nephrectomy. The study met its primary endpoint of improving DFS and the results were published by The New England Journal of Medicine in October 2016.
- In the S-TRAC trial, the Hazard Ratio (HR) was 0.76 (95% CI: 0.59, 0.98) with a 2-sided p-value=0.03 in favor of Sutent®, representing a statistically significant 24% relative reduction in the risk of a DFS event. The median DFS was 6.8 years (95% CI: 5.8, not reached [NR]) in the Sutent® arm compared with 5.6 years (95% CI: 3.8, 6.6) in the placebo arm. At five years, the DFS rate for patients receiving Sutent® was 59.3% and 51.3% for placebo. This represents a persistent 8% absolute benefit.
- No new safety signals were identified in the S-TRAC trial. The most common adverse reactions occurring in ?20% of patients receiving Sutent® for adjuvant treatment of RCC (all grades) were mucositis/stomatitis (61%), fatigue/asthenia (57%), diarrhea (57%), hand-foot syndrome (50%), hypertension (39%), altered taste (38%), nausea (34%), dyspepsia (27%), abdominal pain (25%), rash (24%), hypothyroidism/TSH increased (24%), bleeding events, all sites (24%), and hair color changes (22%). The prescribing information for Sutent® also includes a boxed warning for hepatotoxicity and notes the following warnings and precautions: cardiovascular events; QT Interval Prolongation and Torsades de Pointes; hypertension; hemorrhagic events and viscus perforation; Tumor Lysis Syndrome (TLS); thrombotic microangiopathy (TMA); proteinuria; dermatologic toxicities; thyroid dysfunction; hypoglycemia; osteonecrosis of the jaw (ONJ); wound healing; and embryo-fetal toxicity.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-11-16
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
